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Deep rTMS and Varenicline for Smoking Cessation

Primary Purpose

Tobacco Use Disorder, Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Deep Repetitive Transcranial Magnetic Stimulation (Active)
Deep Repetitive Transcranial Magnetic Stimulation (Sham)
Varenicline
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring smoking cessation, varenicline, deep rTMS, insula, addiction, tobacco use disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65;
  • Nicotine dependent as assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
  • Reported daily cigarette consumption ≥ 10 and expired carbon monoxide (CO) measurement of ≥ 10 ppm;
  • Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
  • Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7.

Exclusion Criteria:

  • Reported smoking abstinence in the 3 months preceding screening visit;
  • Current use of other smoking cessation aids;
  • Allergy and/or contraindication to varenicline or rTMS;
  • Pregnancy, trying to become pregnant or breastfeeding;
  • Current or recent history of cardiovascular or cerebrovascular disease and/or current hypertension;
  • Current or historical evidence of suicidal behavior;
  • Serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.);
  • Current, personal history or family history of seizures;
  • Cognitive impairment as defined as a Mini Mental State Examination (MMSE) score <24;
  • Concomitant use of medication that lowers seizure threshold

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Deep rTMS active + Varenicline

Deep rTMS sham + Varenicline

Arm Description

Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.

Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.

Outcomes

Primary Outcome Measures

Point prevalence abstinence at the end of 12 weeks
Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.

Secondary Outcome Measures

Fagerstrom Test For Nicotine Dependence (FTND) score
This will be used to assess physical dependence severity in participants. It is a 6 item scale and total scores can range from 0-10. A higher score indicates more severe nicotine dependence.
Expired CO Measurements
This will be used as a biological confirmation of recent smoking.
Cigarettes per day (TLFB)
Self-reported measure of cigarette consumption.
Minnesota Nicotine Withdrawal Scale (MNWS) score
This will be used to assess withdrawal symptoms. It is an 8 item scale and total scores range from 0 to 24. A higher score indicates more severe nicotine withdrawal.
Tiffany Questionnaire for Smoking Urges (T-QSU) score
This will be used to assess symptoms of craving/urges for tobacco. It is a 32 item scale and total scores range from 0 to 224. A higher score indicates more severe smoking craving/urges.
Point prevalence abstinence at the end of 4 weeks
Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.
Prolonged abstinence from end of treatment (Week 12) to end of follow up (Week 26)
Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Prolonged abstinence with 2-week grace period at end of follow up (Week 26)
Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Continuous abstinence at 6 months
Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.

Full Information

First Posted
September 6, 2019
Last Updated
April 3, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
Pfizer, Brainsway
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1. Study Identification

Unique Protocol Identification Number
NCT04083144
Brief Title
Deep rTMS and Varenicline for Smoking Cessation
Official Title
Deep rTMS and Varenicline for Smoking Cessation: A Pilot Study Exploring the Efficacy of a Combined Treatment Approach
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Pfizer, Brainsway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of deep repetitive transcranial magnetic stimulation (rTMS) using the insula H-coil on smoking outcomes in smokers receiving varenicline. It is hypothesized that active deep rTMS will improve abstinence rates, attenuate craving and reduce cigarette consumption and dependence severity.
Detailed Description
This study will be a randomized, double-blind, sham-controlled clinical trial. Nicotine dependent participants will be recruited and randomized tor receive either active or sham rTMS intervention for 4 weeks (5 sessions/week). All participants will receive an open-label treatment of varenicline for 12 weeks and weekly counselling sessions. The aims of the study are: To examine the efficacy of bilateral deep rTMS to the insula on point prevalence smoking abstinence in smokers receiving varenicline treatment. To examine the efficacy of bilateral deep rTMS to the insula on other smoking outcomes such as craving, cigarette smoking and dependence severity. To examine the effect of bilateral deep rTMS to the insula on abstinence at the end of rTMS treatment and at 6-month follow up. Abstinence will be measured by point prevalence at week 4 and 12 and prolonged continuous abstinence at week 26. This will be confirmed using plasma cotinine levels. All other measures will be done using various questionnaires such as Fagerstrom Test of Nicotine Dependence (FTND), Timeline Follow-Back (TLFB), Minnesota Nicotine Withdrawal Scale (MNWS), and Tiffany Questionnaire of Smoking Urges (T-QSU).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Smoking Cessation
Keywords
smoking cessation, varenicline, deep rTMS, insula, addiction, tobacco use disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep rTMS active + Varenicline
Arm Type
Active Comparator
Arm Description
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Arm Title
Deep rTMS sham + Varenicline
Arm Type
Sham Comparator
Arm Description
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Intervention Type
Device
Intervention Name(s)
Deep Repetitive Transcranial Magnetic Stimulation (Active)
Intervention Description
Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Intervention Type
Device
Intervention Name(s)
Deep Repetitive Transcranial Magnetic Stimulation (Sham)
Intervention Description
Sham deep rTMS using the H-coil. The sham coil is built into the same helmet as the active coil. It mimics the active coil with regards to acoustics and scalp sensations.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Champix
Intervention Description
12 week course treatment of varenicline (0.5 mg/1 mg) using the standard dosage schedule for smoking cessation (Day 1-3: 0.5 mg daily; day 4-7: 0.5 mg twice a day; day 8-end of treatment: 1 mg twice a day).
Primary Outcome Measure Information:
Title
Point prevalence abstinence at the end of 12 weeks
Description
Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fagerstrom Test For Nicotine Dependence (FTND) score
Description
This will be used to assess physical dependence severity in participants. It is a 6 item scale and total scores can range from 0-10. A higher score indicates more severe nicotine dependence.
Time Frame
26 weeks
Title
Expired CO Measurements
Description
This will be used as a biological confirmation of recent smoking.
Time Frame
26 weeks
Title
Cigarettes per day (TLFB)
Description
Self-reported measure of cigarette consumption.
Time Frame
26 weeks
Title
Minnesota Nicotine Withdrawal Scale (MNWS) score
Description
This will be used to assess withdrawal symptoms. It is an 8 item scale and total scores range from 0 to 24. A higher score indicates more severe nicotine withdrawal.
Time Frame
26 weeks
Title
Tiffany Questionnaire for Smoking Urges (T-QSU) score
Description
This will be used to assess symptoms of craving/urges for tobacco. It is a 32 item scale and total scores range from 0 to 224. A higher score indicates more severe smoking craving/urges.
Time Frame
26 weeks
Title
Point prevalence abstinence at the end of 4 weeks
Description
Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.
Time Frame
4 weeks
Title
Prolonged abstinence from end of treatment (Week 12) to end of follow up (Week 26)
Description
Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Time Frame
26 weeks
Title
Prolonged abstinence with 2-week grace period at end of follow up (Week 26)
Description
Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Time Frame
26 weeks
Title
Continuous abstinence at 6 months
Description
Measured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65; Nicotine dependent as assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM-V); Reported daily cigarette consumption ≥ 10 and expired carbon monoxide (CO) measurement of ≥ 10 ppm; Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4; Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7. Exclusion Criteria: Reported smoking abstinence in the 3 months preceding screening visit; Current use of other smoking cessation aids; Allergy and/or contraindication to varenicline or rTMS; Pregnancy, trying to become pregnant or breastfeeding; Current or recent history of cardiovascular or cerebrovascular disease and/or current hypertension; Current or historical evidence of suicidal behavior; Serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.); Current, personal history or family history of seizures; Cognitive impairment as defined as a Mini Mental State Examination (MMSE) score <24; Concomitant use of medication that lowers seizure threshold
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Le Foll, MD,PhD,MCFP
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36160428
Citation
Ibrahim C, Malik S, Barr MS, Blumberger DM, Daskalakis ZJ, Le Foll B. Insula deep rTMS and varenicline for smoking cessation: A randomized control trial study protocol. Front Pharmacol. 2022 Sep 8;13:969500. doi: 10.3389/fphar.2022.969500. eCollection 2022.
Results Reference
derived
Links:
URL
https://www.camh.ca/en/science-and-research
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching

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Deep rTMS and Varenicline for Smoking Cessation

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